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临床试验/NCT03226730
NCT03226730已完成不适用

Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger

University of California, San Diego2 个研究点 分布在 2 个国家目标入组 2,898 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,898
试验地点
2
主要终点
Intentions to Use Contraception Questionnaire

研究概览

简要总结

This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents (RMA) Interventions developed and implemented by Pathfinder International to increase contraception use and contraception use intentions among married adolescent girls ages 13-19 in three rural districts of the Dosso region of Niger. Intervention models (gender-synchronized household visits and small groups) will be tested using a randomized 4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as the control group and will not receive any intervention. The quantitative component will consist of collecting quantitative baseline, 16-months follow-up, and 27-months survey data from randomly selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating in each Arm of the study. Qualitative elements will include ethnography at two time points and semi-structured in-depth interviews half way through intervention implementation. A costing and cost effectiveness analysis will also be conducted to evaluate which intervention provides the largest gain in the primary outcomes for each dollar spent.

详细描述

This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents (RMA) Interventions to increase contraception use and contraception use intentions among married adolescent girls ages 13-19 in three rural districts of the Dosso region of Niger. Two intervention models (gender-synchronized household visits and small groups) will be tested using a randomized 4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as the control group and will not receive any intervention. The quantitative component will consist of collecting quantitative baseline and 16-months follow-up survey data from randomly selected married adolescent girls (n=1200) and their husbands (n=1200) who are participating in each Arm of the study. Qualitative elements will include ethnography at two time points and semi-structured in-depth interviews half way through intervention implementation. A costing and cost effectiveness analysis will also be conducted to evaluate which intervention provides the largest gain in the primary outcomes for each dollar spent.

Quasi-Experimental Quantitative Evaluation Design. The 4-arm RMA outcome evaluation will take place across 48 villages clustered within the 3 districts (i.e., 16 villages per district) in the Dosso region of Niger; specifically, Loga, Doutchi and Dosso. Each of the 3 districts will be assigned to 1 of the 3 intervention conditions. Within each district, 16 comparable villages (i.e., rural, Hausa or Zarma-speaking, at least 1000 inhabitants, similar wealth distribution profile, and located within the specified range of distance from health facilities providing effective contraception) will be randomly selected to be assigned to either the district-specific intervention arm or to the control condition. A stratified randomization approach will be used, in which villages will be stratified into two groups based on the village having or not having a health center co-located in their village. Specifically, within each district, 8 villages will be randomly selected among those that have a co-located health center, and 8 villages will be randomly selected from among those villages that do not have a co-located health center (all within the parameters listed above). Within each of these 2 groupings of 8 villages, 2 villages will be randomly selected to be assigned to the control arm. Thus, 12 villages will be assigned to the intervention and 4 will be assigned to serve as control villages in each district. Each village will act as a cluster, with the unit of analysis being the married female adolescent (ages 13-19 years).

Qualitative Evaluation Design. This evaluation study will employ qualitative methods to complement the proposed quantitative evaluation design. The first method employed will be ethnography (i.e., participant observation, in-depth interviewing, informal discussions) to explore the processes related to changing understanding, intentions and behaviors related to use of modern contraception in the context of participating in the RMA interventions. Three villages in Arm 3 receiving the full complement of the RMA programs (i.e., male and female household visits, and male and female groups) will be the source for ethnographic observational field notes, informal group discussion field notes, and informal interview field notes. Three pairs of trained, local research assistants (6 total; 2 per village) will live with families of adolescent wife participants who are living in three separate villages and will participate in the daily life of the families and broader community (cooking, cleaning, farming, etc.) for a period of two month total, one month corresponding with 3 months and 14 months after program initiation. Research assistants will observe but not participate in household visit and small group interventions. Additionally, they will conduct informal, open-ended interviews and consultations with key respondents throughout the community (male and female RMA participants, older adults including in-laws, local political, business and religious leaders).

Findings of the ethnographic phase will inform a semi-structured interview phase to capture narratives regarding intervention acceptability and the roles of the RMA program in increased knowledge, altered intention and changed behaviors regarding decisions on use of modern contraception, inclusive of a focus on issues of gender equity and persistent barriers to contraception acceptance and use. Forty-eight adolescent wives and husbands of adolescent wives participating in the RMA program, and key informants (e.g., village leaders, health providers, etc.) from intervention Arms 1 and 2 will provide semi-structured interview data (n=24 interviews per study arm). Semi-structured interviews (60 minutes) will be conducted approximately 8 months after implementation is initiated. These data will, in turn, inform the foci of the second round of ethnography to be collected at 14 months post program initiation.

Costing and cost-effectiveness will be calculated for each study arm. If one or more intervention arms are found to be effective at increasing contraception use or intention to use contraception, the investigators will compare the cost effectiveness of achieving the outcomes using the WHO-CHOICE methodology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •13-19 years old
  • •Fluent in Hausa or Zarma
  • •Residing in the village where recruitment is taking place with no plans to move away in next 18 months or plan to travel for more than 6 months during that period
  • •Providing informed consent.
  • •Must be the husband to an eligible adolescent participating in the study
  • •Hausa or Zarma speaking
  • •Providing informed consent.

排除标准

  • •Plans to move away in next 18 months or plans to travel for more than 6 months during that period;
  • •Currently sterilized (to enable measurement of changes in use of temporary methods of contraception from baseline to 16-months follow-up)

研究组 & 干预措施

Arm 1: Household Visits

Experimental

Arm 1 will receive gender synchronized household visits (i.e., visits by a female community health worker to the participating married adolescent female and visits by a male community health worker to the participating husband of the married adolescent female). Approximately 10-12 visits with wives and 4-6 visits with husbands are expected to take place over the course of the project. Study Arms 1-3 will additionally receive community enabling environment activities and adolescent-specific service delivery activities to support adolescent contraception use. Community enabling environment activities will include engaging religious leaders, community leaders, and familial gatekeepers of the married adolescent wives, such as in-laws, in community dialogues on a monthly basis.

干预措施: Household Visits (Behavioral)

Arm 2: Small Groups

Experimental

This arm will receive, in addition to the community-level components, gender synchronized group-based interventions (i.e., separate group-based interventions for husbands of adolescent wives and adolescent wives, themselves). Male-only and female-only small groups for participating husbands and wives will be held separately on bimonthly and monthly intervals, respectively. In this project, each small group will consist of 10-15 participants and will be held in places participants have deemed safe spaces (e.g., a place that has auditory and visual privacy, is safe for girls to walk to, has been designated by community leaders as a protected place for girls to meet). Approximately 8-10 female small groups and 4-6 male groups are expected to take place over the course of the project.

干预措施: Small Groups (Behavioral)

Arm 3: Household Visits + Small Groups

Experimental

In addition to the community enabling environment components, this arm will receive a combination of household visit and small groups intervention components, as described above for Arms 1 and 2, in order to understand the combined effect of these two interventions on the outcomes of interest.

干预措施: Household Visits (Behavioral)

Arm 3: Household Visits + Small Groups

Experimental

In addition to the community enabling environment components, this arm will receive a combination of household visit and small groups intervention components, as described above for Arms 1 and 2, in order to understand the combined effect of these two interventions on the outcomes of interest.

干预措施: Small Groups (Behavioral)

Arm 4: Control

No Intervention

The fourth arm will serve as the control condition. Individuals in these villages will not receive the household, small group, or community-enabling environment intervention components.

结局指标

主要结局

Intentions to Use Contraception Questionnaire

时间窗: baseline and 18 month follow up

Change in behavioral intentions regarding effective contraceptive use (next 3 months)

Contraception Use Questionnaire

时间窗: baseline and 18 month follow up

Change in use of effective methods of contraception (methods assessed individually)

次要结局

  • Knowledge of effective contraceptive methods Questionnaire(baseline and 18 month follow up)
  • Social norms regarding gender equity Questionnaire(baseline and 18 month follow up)
  • Acceptance of effective contraceptive methods Questionnaire(baseline and 18 month follow up)
  • Female Empowerment Questionnaire(baseline and 18 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay G. Silverman, PhD

Professor

University of California, San Diego

研究点 (2)

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